[Reporter’s View] Doctors agree Korea’s reimb is too slow

Even prescribing physicians believe that the pace of new drug reimbursement listing in Korea is too slow.

 

This is an issue not only for doctors or patients, but obviously for pharmaceutical companies as well.

 

Recently, the Korean Research-based Pharmaceutical Industry Association (KRPIA) released the results of a survey of 100 medical professionals in Korea.

 

In January, a global polling agency Ipsos Research surveyed domestic clinical experts from various medical departments to ask their opinions on access to new drugs in Korea.

 

According to the survey results, all medical professionals unanimously answered that the period required for MFDS approval to health insurance coverage is “long,” with 74% stating it is “too long.” Regarding the appropriate period from approval to health insurance coverage, 81% of medical professionals answered “up to 10 months,” with 41% deeming “within 6 months” as appropriate.

 

As of 2022, it took an average of 608 days (approximately 20 months) for innovative new drugs to be approved by the MFDS and listed for health insurance reimbursement in Korea.

 

This is twice the appropriate period (10 months) cited by most medical professionals and significantly longer than what is required for other major countries such as Germany (281 days), Japan (301 days), and France (311 days).

 

Furthermore, experts who directly treat patients on-site responded that the widespread introduction of innovative new drugs would be of practical help in treating patients.

 

Eighty-three percent of medical professionals expected that “if drugs already in common use overseas are covered by health insurance in Korea, patient treatment outcomes will improve significantly.” A large proportion of medical professionals (85%) also responded that “if reimbursement criteria are relaxed to enable early or wider scope of use, even for drugs already covered by health insurance, this will significantly improve patient treatment outcomes.” In addition, 95% of medical professionals urged the MOHW to introduce a “fast-track listing procedure or system” for health insurance coverage, similar to the MFDS's Global Innovate Products on Fast Track (GIFT) system, which shortens the drug approval review period for severe or life-threatening diseases by up to 75%.

 

Medical professionals who participated in the survey also expressed concerns about Korea's low access to new drugs.

 

Ninety-four percent pointed out that “access to new drugs in Korea is lower than overseas,” and 97% answered that “the government must set appropriate and reasonable drug prices to prevent the ‘Korea Passing’ phenomenon, where multinational pharmaceutical companies abandon the launch of innovative new drugs due to domestic regulations on pharmaceuticals.” Although this is a recurring issue, the criticism carries more weight as it comes from the front lines of medical care.

 

Of course, the government is not without effort.

 

Every year, health authorities introduce various systems to improve the speed of drug listing.

 

The “parallel approval-evaluation-negotiation pilot project” is already in its second phase.

 

In addition, the deadlines for regulations of drugs that go through the general listing process are being shortened in general, in both the evaluation and negotiation stages of the Health Insurance Review and Assessment Service and the National Health Insurance Service.

 

However, whether the process is really speeding up remains in question.

 

The problem lies in the process of enforcing regulations.

 

No matter how well the system supports prompt reimbursement of drugs, there are always factors that can cause delays.

 

Ultimately, patients are the ones left to suffer.

 

They are left to wait anxiously, without a clue about what will happen next.

 

Measures to shorten the process of listing drugs for insurance reimbursement must be accompanied by greater transparency and disclosure.